Quality & Compliance Manager

We have an exciting mid-shift opportunity available for a Quality & Compliance Manager. Work from home or the office – you choose!

When you join Yempo, you’ll receive the following fantastic benefits:

• Highly competitive salary – paid weekly!
• HMO enrollment upon commencement
• Additional HMO dependents added each year of service
• 20 vacation days per year; 7 sick days
• Annual performance bonuses and incentives
• Annual salary reviews and increases
• Free cooked rice, snacks and hot drinks
• Company polo shirts provided
• Fantastic, bright and cheerful open-plan work environment
• Prestigious clients and highly professional and friendly co-workers

Our Client
In this position, you will be assigned to our UK-based client, a global med-tech company who are experts in infection prevention and control.

About the Role

The ISO 13485 Specialist will be responsible for planning, implementing, achieving and maintaining ISO 13485 certification. This role will act as the subject‑matter expert and owner of the ISO 13485 Quality Management System (QMS), ensuring it is fully embedded across the business and aligned with product design, manufacturing, and post‑market activities.

The role is critical to supporting the client’s medical device strategy, regulatory compliance, and continued growth in regulated healthcare markets.

Your Responsibilities

• Lead the end‑to‑end planning and implementation of ISO 13485
• Develop and maintain the ISO 13485 Quality Management System, ensuring full compliance with the standard
• Define and deliver a clear certification roadmap, including gap analysis, implementation plans, and timelines
• Work cross‑functionally to embed ISO 13485 requirements into design, development, procurement, manufacturing, and post‑market processes
• Act as the primary point of contact for external certification bodies and auditors
• Plan, coordinate, and lead internal audits, ensuring readiness for external assessments
• Support and manage Stage 1 and Stage 2 certification audits, surveillance audits, and recertification
• Own the management of non‑conformances, corrective and preventive actions (CAPA), and root cause analysis
• Ensure document control, record management, and version control meet ISO 13485 requirements
• Maintain and continuously improve the ISO 13485 QMS to ensure it remains effective, compliant, and proportionate
• Deliver training and awareness sessions to ensure teams understand their responsibilities under ISO 13485
• Support regulatory alignment with related requirements (e.g., MDR, technical files, risk management)
• Adherence to the company management systems and QHSES responsibilities as defined within the ‘overview and context of the organization’ document.

Your Background

• In-depth knowledge of ISO standards, regulatory requirements, and quality management systems.
• Proven experience in a quality and compliance leadership role
• Strong organizational and leadership skills.
• Excellent communication and interpersonal abilities.
• Proven experience of managing and maintaining certified ISO management systems
• Experience working with and ideally implementing ISO 13485 into an organization.
• Experience in product and chemical compliance, including regulatory submissions.
• Manufacturing or engineering-related background is highly desirable

Disclaimer for salary ranges. Yempo provides an indicative range of salary that we deem relevant for the advertised role. This may be adjusted for the skills and experience of the selected candidate.